Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02798861
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2016-06-02
Brief Title:
Controlled Attenuation Parameter CAP in Liver Allografts
Sponsor:
Andres Duarte-Rojo
Organization:
University of Pittsburgh
Study Overview
Official Title:
Usefulness of Controlled Attenuation Parameter CAP for the Assessment of Liver Steatosis in Liver Donors
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference Secondarily investigators will correlate transient elastography TE and CAP results analyze possible associations between CAPTE and post-liver transplant LT clinical outcomes and evaluate the change in CAP after LT The study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts
Detailed Description:
This is a coordinated study utilizing 3 recruitment centers University of Arkansas for Medical Sciences UAMS Stanford University and Mayo Clinic 2 liver pathology reading centers University of Michigan and Mayo Clinic and 1 coordinating center University of Arkansas The cohort study with a cross-sectional component for the primary aim has been completed through independent Institutional Review Board IRB agreements at UAMS Stanford University and the Mayo Clinic The samples collected at the three recruitment centers will be sent to the biopsy center at the University of Michigan and Mayo Clinic for evaluation The Liver Transplant Program at each of the 3 recruiting centers will identify study subjects during the process of liver allocation to their listed recipients Criteria for recruitment are as follows
Inclusion criteria - Liver Recipient
Men and women Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor
Valid TE with Fibroscan 530 defined as
At least 10 valid measurements
Interquartile Range IQRMedian stiffness value 30 only in cases with 71 kPa Exclusion criteria - Liver Recipient
Patient did not undergo liver transplantation Exclusion criteria - Liver Donor
Donation after circulatory death DCD
No liver biopsy obtained during organ procurement process
Inclusion criteria - Liver Recipient
Men and women Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor
Valid TE with Fibroscan 530 defined as
At least 10 valid measurements
Interquartile Range IQRMedian stiffness value 30 only in cases with 71 kPa Exclusion criteria - Liver Recipient
Patient did not undergo liver transplantation Exclusion criteria - Liver Donor
Donation after circulatory death DCD
No liver biopsy obtained during organ procurement process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None